Comparative Legal Approaches on Patenting Human Stem Cells with Emphasis on European & American Jurisprudence

Stem cells are one of the most challenging areas of patent law as one of the important medical resources for the treatment of various diseases. The scope of this challenge relying on the legal approaches of countries depends on how to satisfy substantive requirments and moral considerations, especially in the field of embryonic stem cells. Accordingly, although such cells could be considered patentable subject matter on the basis of substantive requirements, they may not be commercially exploited as an invention on the basis of some considerations of public order and morals. An examination of the relevant case law in the European Union and the United States shows the differences in their approach. The greater emphasis of United States is on the compatibility of such inventions with the patentability requirements and the EU's tendency is more on their compliance with moral considerartions. With the advancement of technology and the achievement of different types of stem cells in ways other than embryo destruction such as somatic cell nuclear transfer technology, induced pluripotent stem cells and so on the legal issues surrounding the patentability of these cells have changed. In fact, because of accessibility to these cells without the destruction of the embryo and the processes that take place on them, like what happens in induce pluripotent stem cells, such inventions can no longer completely ignore because of its similarity to the natural state in human body or conflict with protecting human dignity. In this paper, the legal approaches to patenting human stem cells based on recent European and US jurisprudence have been reviewed and the present research method is analytical-comparative based on library studies. Finally concludes that despite the differing approaches, patenting these cells has been increasing, especially because of their important and numerous therapeutic applications and the related challenges have been adequately managed through judicial procedures. Please cite this article as: Gholami S, Parvin MR. Comparative Legal Approaches on Patenting Human Stem Cells with Emphasis on European & American Jurisprudence. Iran J Med Law 2020; 14(53): 199-232.